Medical Design Briefs - November 2021 - 13

HONORABLE MENTIONS
reconnected within two to four minutes,
the patient will die, or suffer catastrophic
(permanent) brain injury.
Solution: The POPSafe™ Tracheostomy
Tube Set is a patented medical
device that eliminates these deadly accidental
ventilator pop-off disconnect
events. The POPSafe Tracheostomy
Tube Sets are the only products
addressing the failure root cause of accidental
ventilator disconnections. The
POPSafe Tracheostomy Tube Sets will be
the first and only FDA 510(k) cleared
tracheostomy tube sets that include the
patented ventilator elbow connector
and patented overpressure relief safety
valve. POPSafe is a game-changer for
ventilator-dependent patients (and their
families) because the developer notes
that " there are no pop-offs with
POPSafe!™ "
The target audience for POPSafe
Tracheostomy Tube Set is the ~250,000
ventilator-dependent patients in the
United States and their families. The
U.S. market size for this product type
is $1.5 billion annually. Of these
250,000 patients, ~63 percent of these
patients will utilize the product in
home care or long-term care facilities;
and ~37 percent of these patients
receive care in hospitals, including
ICUs and CCUs.
POPSafe Tracheostomy Tube Sets
include several components and are
prescription devices. The POPSafe
Trache ostomy Tube Set will cost the
same as current products and will be
priced at ~$170, which is within the
Medicare reimbursement price range
for current standard of care tracheostomy
device sets. The annual spend per
patient (ASP) for tracheostomy tube
sets is ~$6,000 and is reimbursed by
Medicare.
Fuller and her team have developed
advanced POPSafe tracheostomy tube
Robertsite® Bag Access Valves (BAV)
Designed to be integrated by press fi t or
heat sealing into fl uid delivery bags
6.6mm
Tube Port
6.6mm
Tube Port (PP)
6.0/6.6mm
Break Off
◊ Eliminates the use of needles and spikes
◊ Compatible with all standard male luers
sales@halkeyroberts.com
727.471.4200
www.halkeyroberts.com
sales@halkeyroberts.com
727.471.4200
h lk b t
Medical Design Briefs, November 2021
Cov
Eliminates the use of needles and spikes
◊ Compatible with all standard male luers
◊ Eliminates leaking and
dripping when disconnected
◊ Eliminates leaking and
◊ Incorporates proven split septum valve technology
◊ Available in polycarbonate and polypropylene
dripping when disconnected
Visit our website to view our comprehensive line of needlefree swabable valves
Visit our website to view our comprehensive line of needlefree swabable valves
Free Info at http://info.hotims.com/79419-764
ToC
13
Incorporates proven split septum valve technology
◊ Available in polycarbonate and polypropylene
prototypes and successfully conducted
simulated clinical use testing (mannequins)
with clinicians, with compelling
results. " We have angel investments
from an ENT surgeon and RN,
who have dealt with their patient's popoff
events, firsthand, " says Fuller. " We've
been asked to partner with a veteranowned
medical device manufacturer
and distribution company. We continue
to develop POPSafe per FDA design control
requirements. "
The 2019 U.S. Dept. of Veterans
Affairs, Office of Inspector General's
Office of Healthcare Inspections
report on the investigation of a
ventilator- dependent patient death
determined pop-off to be the primary
cause for the patient's death. One of
the five OIG recommendations from
this report is to implement policies for
use of ventilator anti-disconnect de -
vices; POPSafe is a ventilator antidisconnect
device, which will be GMP
manufactured similarly to currently
available tracheostomy tube devices.
POPSafe™ Tracheostomy Tube Set is currently
under development and not yet commercially
available.
http://info.hotims.com/79419-764
Medical Design Briefs - November 2021

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